Dr. Marty McCurry, December 12, 2018, New York City.
Noam Garai | Getty Images
A version of this article first appeared in CNBC’s Healthy Returns newsletter, which delivers the latest healthcare news straight to your inbox. To receive future editions, subscribe here.
Happy Tuesday! President-elect Donald Trump’s election to head the Food and Drug Administration appears to be allaying fears that the next four years will bring major disruption to the biotech and pharmaceutical industries.
President Trump on Friday nominated Dr. Marty McCurry, a pancreatic surgeon at Johns Hopkins University, to be FDA commissioner. If confirmed by the Senate, Mr. McCurry would be responsible for regulating food, thousands of vaccines, other pharmaceuticals, medical devices and tobacco products.
She noted that President Trump’s more controversial nomination of Robert F. Kennedy Jr., a prominent vaccine skeptic and former environmental lawyer, to head the Department of Health and Human Services, which also requires Senate confirmation. will answer.
Both Mr. Kennedy and Mr. McCulley have publicly criticized federal health agencies, and both recently accused the government of not prioritizing chronic disease.
But unlike Kennedy, McCurry has a more traditional health background as an experienced physician. Mr. McCurry is also an executive at Sesame, a telemedicine company that connects consumers with doctors who can prescribe compound versions of popular weight-loss drugs.
BMO Capital Markets analyst Evan Sagerman said in a note Sunday that Mr. McCulley is likely to take a “more rational approach to operating the FDA than feared,” and that Mr. McCulley is likely to take “a series of U.S. He is knowledgeable about medical care and seems to be cooperative.” Evidence-based medical interventions. ”
“Overall, the FDA selection provides respite for biopharma investors, removes uncertainty, and potentially reverses significant losses the week RFK Jr. was nominated as HHS Secretary. “I think so,” Zeigerman said.
Some health experts and investors worry that President Trump will elect someone without a proper medical background to lead the FDA, politicizing the agency’s drug regulatory process and encouraging new product approvals and innovation. There were concerns that this could pose a broader threat to the
“McQuarrie will promote technology and innovation in a way that provides some respite for those who fear the sector will become more aligned with various virtues,” Jared Holtz, healthcare equity strategist at Mizuho, said in an email last week. I hope so.”
He added that Mr. McCurry’s “knowledge of the (health care) industry is likely to be frequently noted.”
So what does McCurry think about America’s health?
Mr. McCurry has long been a vocal challenger to the American medical establishment, researching and publishing books on topics such as high medical costs, lack of transparency, and medical errors.
Although McCulley does not appear to share Kennedy’s anti-vaccine views, he has recently made statements in support of Kennedy’s Make America Healthy Again Platform. “The biggest perpetrator of misinformation is the U.S. government with the food pyramid,” McCurry said earlier this year.
McCurry has been a controversial figure in other ways, especially during the coronavirus pandemic. In some ways, he aligned himself with traditional public health experts in favor of universal masking and early vaccination.
But Mr. McCurry also opposed making vaccines mandatory and questioned the value of booster shots for children. He also questioned lockdowns, among other measures promoted by public health authorities. Additionally, he has emerged as a critic of the FDA during the pandemic, accusing the agency of moving too slowly to approve certain products against the coronavirus.
Zeigerman said Markery’s ability to help patients make informed choices could lower the hurdles for product approval. This problem is likely to be offset by higher hurdles for disclosing a drug’s risks and benefits to patients and increased requirements for post-approval treatment monitoring.
“In our view, Dr. McCurry’s willingness to be critical of the system, offer flexible and reasoned opinions, and support patient choice is positive,” Sagerman said.
But Sagerman said he was far more cautious about Trump’s nomination of Florida physician and Republican congressman Dave Weldon to lead the Centers for Disease Control and Prevention. That’s because of Mr. Weldon’s long history of criticizing vaccinations.
We’ll be watching closely to see if President Trump’s health nominations are approved by the Senate, so stay tuned for more coverage.
Please feel free to send tips, suggestions, story ideas, and data to Annika at annikakim.constantino@nbcuni.com.
Latest Healthcare Technology: Neuralink Approves New Study, Company Announces
Jonathan Ra | Null Photo | Getty Images
Elon Musk’s neurotech startup Neuralink announced Monday that a new clinical trial has been approved to evaluate whether patients can use brain implants to control an assistive robotic arm.
Neuralink is building a brain-computer interface (BCI) that allows people with paralysis to control external devices such as computers and smartphones with their thoughts. According to Neuralink’s website, the company’s flagship implant records neural signals using 64 “threads” inserted directly into the brain.
Two human patients have been implanted with the BCI so far as part of Neuralink’s PRIME study, which aims to prove the system is safe and useful. Neuralink’s new trial, called the “CONVOY study,” will investigate whether patients can use the same BCI to operate a robotic arm, the company said in a post on X (also owned by Musk). Patients can be cross-enrolled in both studies.
“This is an important first step towards restoring not just digital freedom, but physical freedom,” Neuralink said in a post.
It was not immediately clear when the study would begin or how many patients would participate. According to X’s post, Neuralink plans to share more information about the study.
The company did not respond to CNBC’s request for comment.
Neuralink announced last week that it had been approved to begin its first international clinical trial in Canada. Similar to the PRIME study, the purpose of the Canadian trial is to prove the safety and effectiveness of Neuralink technology, according to the blog post.
Patients with quadriplegia due to spinal cord injury or degenerative diseases such as amyotrophic lateral sclerosis (ALS) may be eligible to participate, and recruitment has already begun, Neuralink said in a post on X. Ta.
BCIs have been studied in academia for decades, and competition within the industry has increased in recent years. In addition to Neuralink, companies such as Synchron, Paradromics, and Precision Neuroscience are developing their own BCI systems.
Although some of these groups are conducting human trials, no BCI companies have received approval from the U.S. Food and Drug Administration to commercialize their devices.
Feel free to send tips, suggestions, story ideas, and data to Ashley at ashley.capoot@nbcuni.com.